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The Movement of Botulinum Toxin Through the Lateral Gastrocnemius Muscle in Humans: An Expanded Examination

NCT03367429 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2021-12-29

Study results available
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Summary

Despite the wide-spread use of botulinum toxin (BT) to treat spasticity (increased muscle tone) in central neurological disease, evidence-based guidance on dosing, dilution, and injection technique is limited. The wide-spread use of BT in spasticity management, expense of these agents, and detrimental impact from movement into non-injected muscles mandates a better understanding of BT movement within muscles. A proof-of-concept paper written by investigators at Weill Cornell Medicine introduced a non-invasive MRI approach with "voxel thresholds" that was able to detect intramuscular effects of BT at 2 and 3 months post-injection of BT. The purpose of the current set of studies is to refine this MRI technique to better visualize the movement of botulinum toxin through muscle. In addition, the investigators plan to explore, using the imaging technique, how spastic muscle and differing dilutions affect BT movement in an effort to support the development of better research techniques to study toxin movement in human muscle.

Conditions

Interventions

DRUG

Botox

THE PROTOCOL DESCRIPTION ATTEMPTED TO OUTLINE A CONTINGINECY PLAN- MOVING TO ONE OF TWO METHODOLOGOIES DPENDING ON PRELIMINARY FINDINGS. UNFORTUNATLEY, OVER 2 YEARS RECRUITMENT WAS GROSSLY INADEQUATE PREVENTING ANY TYPE OF EVEN CURSURY PRELIMINARY DATA ANALYSIS AND FORCING THE EARLY TERMINATION OF THIS STUDY. MICHAEL W. O'DELL, MD

Sponsors & Collaborators

  • Allergan

    collaborator INDUSTRY

  • Weill Medical College of Cornell University

    lead OTHER

Principal Investigators

  • Michael O'Dell, M.D. · Weill Medical College of Cornell University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-15
Primary Completion
2019-09-18
Completion
2019-09-18
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03367429 on ClinicalTrials.gov